April 26, 2007 — A consent decree of permanent injunction has been entered in Texas district court against PharmaFab Inc, its subsidiary PFab LP, and 2 top company officials to stop their manufacture and distribution of illegal drugs, the US Food and Drug Administration (FDA) announced in a news release.
The medications are considered unsafe because they were not made according to the required current good manufacturing practice (CGMP) and many also lack FDA approval, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.
More than 100 prescription and over-the-counter products are included in the action, including cough and cold products, ulcer treatments, and postpartum hemorrhage products, the FDA said. Consumers who have used these products should consult with their physician.
Affected products include but are not limited to: De-Congestive sustained-release capsules, GFN 1200/DM 60/PSE 60 extended-release tablets, Rhinacon A tablets, Sudal 12 chewable tablets, Histex PD 12 suspension, Atuss HX CIII, Ergotrate tablets, and hyoscyamine sulfate time-release capsules.
Infractions cited in the court complaint include the company's noninvestigation of manufacturing failures, failure to record and justify deviations from written manufacturing procedures, lack of an effective quality control unit, and failure to establish reliable product expiration dates.
As a result of the decree, certain illegal drugs must be destroyed and distribution of all others halted until CGMP compliance and FDA approval requirements are met. If distribution is resumed, the company is required to retain an auditor to conduct facility inspections for 5 years and provide reports to the FDA regarding the company's compliance with CGMP and labeling requirements. In the event of future violations, the FDA may respond with recalls or shutdown and obtain damages of $5000/day and $1000/violation up to a maximum of $5 million a year.
"FDA will not hesitate to pursue enforcement action when necessary," Margaret O'K. Glavin, FDA's associate commissioner for regulatory affairs, says in the news release. "We will continue to protect public health by carefully monitoring the provisions of this injunction. FDA will also continue to investigate and take action against other marketers of unapproved drugs."
Medscape Medical News © 2007 Medscape
Cite this: Yael Waknine. FDA Injunction Halts Distribution of Illegal PharmaFab Drugs - Medscape - Apr 26, 2007.